FINGOLIMOD NEURAXPHARM 0.5 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Fingolimod Neuraxpharm 0.5 mg hard capsulesEFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Fingolimod Neuraxpharm and what is it used for
2. What you need to know before taking Fingolimod Neuraxpharm
3. How to take Fingolimod Neuraxpharm
4. Possible side effects
5. Storage of Fingolimod Neuraxpharm
6. Package contents and additional information

1. What is Fingolimod Neuraxpharm and what is it used for

What is Fingolimod Neuraxpharm

The active ingredient of this medication is fingolimod.

What Fingolimod Neuraxpharm is used for

This medication is used in adults and in children and adolescents (from 10 years of age and older) to treat relapsing-remitting multiple sclerosis (MS) (with relapses), particularly in:

• Patients who do not respond to treatment despite MS treatment.

or

• Patient who rapidly develop severe MS.

This medication does not cure MS, but it helps reduce the number of relapses and slow down the progression of physical disabilities due to MS.

What is multiple sclerosis

MS is a chronic disease that affects the central nervous system (CNS), consisting of the brain and spinal cord. In MS, inflammation destroys the protective sheath (called myelin) that covers the nerves in the CNS and prevents the nerves from functioning properly. This process is called demyelination.

Relapsing-remitting MS is characterized by repeated attacks (relapses) of neurological symptoms that reflect the inflammation occurring in the CNS. Symptoms vary from patient to patient but usually include difficulty walking, loss of sensitivity in some parts of the body (numbness), vision problems, or balance disorders. The symptoms of a relapse may disappear completely when the relapse ends, but some problems may persist.

How Fingolimod Neuraxpharm works

This medication helps combat the attacks of the immune system on the CNS by reducing the ability of some white blood cells (lymphocytes) to move freely within the body and preventing them from reaching the brain and spinal cord. This limits the nerve damage attributed to multiple sclerosis. This medication also reduces some of the immune responses of your body.

2. What you need to know before taking Fingolimod Neuraxpharm

Do not takeFingolimod Neuraxpharm

If any of the above cases apply to you, inform your doctor without taking this medication.

Warnings and precautions

Consult your doctor before starting to take this medication:

If any of the above cases apply to you, inform your doctor before taking this medication.

Slow heart rate (bradycardia) and irregular heartbeats

At the start of treatment or after taking the first dose of 0.5 mg, in the case that your previous dose was changed from 0.25 mg once a day, this medication can cause a decrease in heart rate. As a result, you may feel dizzy or tired, be aware of your heartbeat, or your blood pressure may drop.

If these effects are severe, inform your doctor as you may need immediate treatment.

This medication can also cause irregular heartbeats, especially after the first dose. Irregular heartbeats usually normalize in less than a day. The slow heart rate usually normalizes within a month. During this period, no clinically significant effect on heart rate is usually expected.

Your doctor will ask you to stay in the office or hospital for at least 6 hours, with pulse and blood pressure checks every hour, after taking the first dose of this medication or after taking the first dose of 0.5 mg, in the case that your previous dose was changed from 0.25 mg once a day, so that appropriate measures can be taken in case of adverse effects that appear at the start of treatment. You will have an electrocardiogram before the first dose of this medication and after the 6-hour monitoring period. Your doctor may continuously monitor your electrocardiogram during this time. If after the 6-hour period you have a very slow or decreasing heart rate, or if your electrocardiogram shows abnormalities, you will need to be monitored for a longer period (at least 2 hours more and possibly overnight, until this is resolved). The same may apply if you are resuming this medication after a pause in treatment, depending on both the duration of the pause and how long you were taking this medication before the pause.

If you have or are at risk of having irregular or abnormal heartbeats, if your electrocardiogram is abnormal, or if you have heart disease or heart failure, this medication may not be suitable for you.

If you have suffered from sudden fainting or a decrease in heart rate in the past, this medication may not be appropriate for you. You will be evaluated by a cardiologist (heart specialist) who will advise you on how to start treatment with this medication, including overnight monitoring.

If you are taking other medications that can slow your heart rate, this medication may not be suitable for you. You will need to be evaluated by a cardiologist, who will assess whether you can switch to alternative medications that do not decrease heart rate to allow treatment with this medication. If such a change is not possible, the cardiologist will advise you on how to start treatment with this medication, including overnight monitoring.

If you have never had chickenpox

If you have not had chickenpox, your doctor will check your immunity to the virus that causes it (varicella-zoster virus). If you are not protected against the virus, you will likely need to be vaccinated before starting treatment with this medication. If so, your doctor will delay the start of treatment with this medication for one month after completing the vaccination cycle.

Infections

This medication reduces the number of white blood cells in your blood (especially the number of lymphocytes). White blood cells fight infections. During treatment with this medication (and up to two months after stopping treatment), you may be more likely to get infections. You may even get worse if you already have an infection. Infections can be serious and potentially life-threatening. If you think you have an infection, have a fever, have flu-like symptoms, have herpes (shingles), or have a headache accompanied by stiffness in the neck, sensitivity to light, nausea, rash, and/or confusion or seizures (which can be symptoms of meningitis and/or encephalitis caused by a fungal or herpes virus infection), contact your doctor immediately because it can be serious and life-threatening.

If you think your MS is getting worse (e.g., weakness or vision changes) or if you notice any new symptoms, inform your doctor immediately, as they may be symptoms of a rare brain disorder caused by an infection called progressive multifocal leukoencephalopathy (PML). PML is a serious disease that can cause severe disability or death. Your doctor will assess the need for a magnetic resonance imaging (MRI) scan to evaluate your condition and decide if you need to stop taking this medication.

It has been reported that patients treated with this medication have developed human papillomavirus (HPV) infection, including papilloma, dysplasia, warts, and HPV-associated cancer. Your doctor will assess whether you need to be vaccinated against HPV before starting treatment. If you are a woman, your doctor will also recommend that you have regular HPV check-ups.

Macular edema

Before starting treatment with this medication, your doctor may request an eye examination if you have or have had visual disorders or other signs of inflammation in the central vision area (macula) of the eye, an inflammation or infection of the eye (uveitis), or diabetes.

After starting treatment with this medication, your doctor may request an eye examination after 3 or 4 months of treatment.

The macula is a small area of the retina located at the back of the eye that allows you to see shapes, colors, and details clearly and sharply. This medication can cause inflammation of the macula, and this disorder is known as macular edema. Inflammation usually occurs within the first four months of treatment with this medication.

If you have diabetes or have had an eye inflammation known as uveitis, you are more likely to develop macular edema. In these cases, your doctor will want you to have regular eye checks to detect macular edema.

If you have had macular edema, consult your doctor before continuing treatment with this medication.

Macular edema can cause the same visual symptoms as those produced by an MS attack (optic neuritis). At first, you may not have symptoms. You should inform your doctor of any changes you notice in your vision. Your doctor may want to perform an eye examination, especially if:

• The center of your field of vision becomes blurry or has shadows;
• A blind spot appears in the center of your field of vision;
• You have trouble seeing colors or small details.

Liver function tests

If you have severe liver problems, you should not take this medication. This medication can affect liver function. You may not notice any symptoms, but if you notice a yellowish tint to your skin or the white part of your eyes, unusually dark urine (brown color), pain in your right side of the stomach (abdomen), fatigue, loss of appetite, or nausea and vomiting without apparent cause, inform your doctor immediately.

If you have any of these symptoms after starting treatment with this medication, inform your doctor immediately.

Before, during, and after treatment

Your doctor will request blood tests to monitor your liver function. You may need to interrupt treatment if the results of your tests indicate a problem with your liver.

High blood pressure

Since this medication can cause a slight increase in blood pressure, your doctor will want you to have your blood pressure checked regularly.

Lung problems

This medication has a mild effect on lung function. Patients with severe lung problems or "smoker's cough" are more likely to develop adverse effects.

Blood count

The expected effect of treatment with this medication is to reduce the number of white blood cells in your blood. This effect usually normalizes within two months after stopping treatment. If you need to have blood tests, inform your doctor that you are taking this medication, as they may not understand the results of the tests otherwise. For certain blood tests, your doctor may need more blood than usual.

Before starting treatment with this medication, your doctor will confirm that you have enough white blood cells in your blood and may want to repeat checks regularly. If you do not have enough white blood cells, you may need to interrupt treatment with this medication.

Posterior reversible encephalopathy syndrome (PRES)

A condition called posterior reversible encephalopathy syndrome (PRES) has been rarely reported in patients with MS treated with this medication. Symptoms can include sudden and severe headache, confusion, seizures, and changes in vision. Inform your doctor immediately if you experience any of these symptoms during treatment with this medication because it can be serious.

Cancer

In patients with MS who have been treated with this medication, cases of skin cancer have been reported. Inform your doctor immediately if you notice any nodules on the skin (e.g., shiny nodules with a pearl-like appearance), spots, or open sores that do not heal within weeks. The symptoms of skin cancer can include abnormal growth or changes in skin tissue (e.g., unusual moles) that change color, shape, or size over time. Before starting treatment with this medication, a skin examination is required to check for any skin nodules. Your doctor will also perform regular skin checks during treatment with this medication. If any skin problems appear, your doctor may refer you to a dermatologist, who may decide if it is important to visit you regularly.

In patients with MS who have been treated with this medication, a type of cancer of the lymphatic system (lymphoma) has been reported.

Sun exposure and sun protection

Fingolimod weakens your immune system, which increases the risk of developing cancer, especially skin cancer. You should limit your exposure to the sun and UV rays by:

• wearing protective clothing.
• applying a high UV protection sunscreen regularly.

Unusual brain lesions associated with MS relapses

Rare cases of large and unusual brain lesions associated with MS relapses have been reported in patients treated with this medication. In the case of severe relapses, your doctor will assess the need for a magnetic resonance imaging (MRI) scan to evaluate your condition and decide if you need to stop taking this medication.

Switching from other treatments to fingolimod

Your doctor may switch you directly from interferon beta, glatiramer acetate, or dimethyl fumarate to this medication if there are no signs of treatment-related abnormalities. Your doctor may need to perform a blood test to rule out such abnormalities. After stopping natalizumab, you may need to wait for 2-3 months before starting treatment with this medication. To switch from teriflunomide, your doctor may advise you to wait for a period of time or undergo an accelerated elimination procedure. If you have been treated with alemtuzumab, a thorough evaluation and discussion with your doctor are necessary to decide if this medication is suitable for you.

Women of childbearing age

If this medication is used during pregnancy, it may harm the fetus. Before starting treatment with this medication, your doctor will explain the risks and ask you to take a pregnancy test to ensure you are not pregnant. Your doctor will give you a card that explains why you should not become pregnant while taking this medication and what you should do to avoid becoming pregnant while taking this medication. During treatment and for two months after stopping treatment, you must use an effective contraceptive method (see section "Pregnancy and breastfeeding").

MS worsening after stopping treatment with fingolimod

Do not stop taking this medication or change the dose your doctor has prescribed without discussing it with your doctor first.

Inform your doctor immediately if you think your MS is getting worse after stopping treatment with this medication, as it can be serious (see section 3 "If you stop treatment with fingolimod" and also section 4 "Possible side effects").

Elderly

Experience with this medication in elderly patients (over 65 years) is limited. If in doubt, consult your doctor.

Children and adolescents

This medication should not be administered to children under 10 years of age, as it has not been studied in patients with MS in this age group.

The warnings and precautions mentioned above also apply to children and adolescents. The following information is especially important for children and adolescents and their caregivers:

• Before starting treatment with this medication, your doctor will check your vaccination status. If you have not received certain vaccinations, it may be necessary to administer them before you can start treatment with this medication.
• The first time you take this medication, or when you switch from a daily dose of 0.25 mg to a daily dose of 0.5 mg, your doctor will monitor your heart rate and heartbeats (see the previous section "Slow heart rate (bradycardia) and irregular heartbeats").
• If you have seizures or attacks before taking or while taking this medication, inform your doctor.
• If you suffer from depression or anxiety or if during treatment with this medication you feel depressed or anxious, inform your doctor. You may need closer monitoring.

Other medications and Fingolimod Neuraxpharm

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication. Inform your doctor if you are taking any of the following medications:

• Medications that suppress or modulate the immune system, including other medications used to treat MS, such as interferon beta, glatiramer acetate, natalizumab, mitoxantrone, teriflunomide, dimethyl fumarate, or alemtuzumab. You should not use this medication with these medications because it could intensify the effect on the immune system (see also "Do not use Fingolimod Neuraxpharm").
• Corticosteroidsdue to an added effect on the immune system.
• Vaccines. If you need a vaccine, inform your doctor first. During treatment with this medication and up to two months after stopping it, you should not receive certain types of vaccines (vaccines made with live attenuated viruses) because they can cause the infections they are intended to prevent. Other vaccines may not have the desired effect if administered during this period.
• Medications that slow the heart rate(such as beta-blockers like atenolol). Using this medication with these medications can intensify the effect on the heart rate during the first few days after starting treatment with this medication.
• Medications to treat irregular heartbeats, such as quinidine, disopyramide, amiodarone, or sotalol. If you take any of these medications, you should not use this medication, as it could intensify the effect on irregular heartbeats (see also the section "Do not take Fingolimod Neuraxpharm").
• Other medications:

• protease inhibitors, anti-infective agents such as ketoconazole, azole antifungals, clarithromycin, or telithromycin.
• carbamazepine

3. How to Take Fingolimod Neuraxpharm

Treatment with this medication will be supervised by a doctor with experience in treating multiple sclerosis.

Follow the administration instructions for this medication exactly as indicated by your doctor. If in doubt, consult your doctor again.

The recommended dose is:

Adults:

The dose is one 0.5 mg hard capsule per day.

Children and Adolescents (10 years of age and older):

The dose depends on body weight:

• Children and adolescents with a weight of 40 kg or less: 0.25 mg per day.

This medication is not suitable for pediatric patients with a body weight of 40 kg or less. There are other medications containing fingolimod available at lower doses (such as 0.25 mg hard capsules).

• Children and adolescents with a weight over 40 kg: one 0.5 mg hard capsule per day.

For children and adolescents who start with 0.25 mg per day and later reach a stable weight over 40 kg, the doctor will indicate that they switch to one 0.5 mg hard capsule per day. In this case, it is recommended to repeat the first-dose observation period.

Do not exceed the recommended dose.

This medication is taken orally.

Take this medication once a day with a glass of water. Fingolimod hard capsules should always be swallowed whole, without opening them. You can take this medication with or without food.

Taking this medication at the same time every day will help you remember when to take it.

If you have doubts about the duration of treatment with this medication, consult your doctor or pharmacist.

If you take moreFingolimod Neuraxpharmthan you should

If you have taken more fingolimod than you should, inform your doctor immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to takeFingolimod Neuraxpharm

If you have been taking this medication for less than 1 month and forget to take 1 dose during a whole day, talk to your doctor before taking the next dose. Your doctor may decide to keep you under observation when you take the next dose.

If you have been taking this medication for at least 1 month and have forgotten to take your treatment for more than 2 weeks, talk to your doctor before taking the next dose. Your doctor may decide to keep you under observation when you take the next dose.

However, if you have forgotten to take your treatment for a period of up to 2 weeks, you can take the next dose as planned.

Never take a double dose to make up for forgotten doses.

If you stop treatment withFingolimod Neuraxpharm

Do not stop taking this medication or change the dose to be taken without discussing it with your doctor first.

This medication will remain in your body for up to 2 months after stopping treatment. The number of white blood cells in the blood (lymphocyte count) may remain low during this period, and it is possible that side effects may still occur. After stopping treatment with this medication, you may need to wait for 6-8 weeks before starting a new treatment with another medication.

If you need to restart treatment with this medication after a pause of more than 2 weeks, the effect on heart rate that may occur at the start of treatment may recur, and you will need to be monitored in the doctor's office to restart treatment. Do not restart treatment with this medication after stopping it for more than 2 weeks without consulting your doctor first.

Your doctor will decide if it is necessary to monitor you after stopping treatment with this medication and how to do so. Inform your doctor immediately if you think your multiple sclerosis is getting worse after stopping treatment with this medication, as it could be serious.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Some side effects can be serious or potentially serious

Common(may affect up to 1 in 10 people):

• Cough with expectoration (phlegm), chest discomfort, fever (signs of pulmonary disorders).
• Herpes virus infection (shingles or herpes zoster) with symptoms such as blisters, itching, burning, or skin pain, especially on the upper body or face. Other symptoms you may have are fever and weakness in the early stage of the infection, followed by numbness, itching, or red spots with intense pain.
• Slow heart rate (bradycardia), irregular heart rhythm.
• A type of skin cancer known as basal cell carcinoma (BCC) that often appears as a pearl-like nodule, although it can also have other forms.
• It is known that the population with multiple sclerosis has depression and anxiety more frequently, and these have also been reported in pediatric patients treated with fingolimod.
• Weight loss.

Uncommon(may affect up to 1 in 100 people):

• Pneumonia, with symptoms such as fever, cough, difficulty breathing.
• Macular edema (inflammation in the central vision area of the retina in the eye) with symptoms such as shadows or a blind spot or loss of vision in the visual field, blurred vision, problems seeing colors or details.
• Decreased platelet count, which increases the risk of bleeding or bruising.
• Malignant melanoma (a type of skin cancer that usually develops from an unusual mole). Possible signs of melanoma include moles that change in size, shape, thickness, or color over time, or the formation of new moles. Moles can be itchy, bleed, or ulcerate.
• Seizures, attacks (more frequent in children and adolescents than in adults).

Rare(may affect up to 1 in 1,000 people):

• A disease called posterior reversible encephalopathy syndrome (PRES). Symptoms may include sudden and severe headache, confusion, seizures, and/or visual disturbances.
• Lymphoma (a type of cancer that affects the lymphatic system).
• Squamous cell carcinoma: a type of skin cancer that can appear as a firm red nodule, an ulcer with a crust, or a new ulcer on an existing scar.

Very Rare(may affect up to 1 in 10,000 people):

• Abnormality in the electrocardiogram (inversion of the T wave).
• Tumor related to human herpesvirus 8 infection (Kaposi's sarcoma)

Frequency Not Known(cannot be estimated from available data):

• Allergic reactions, including symptoms of rash or hives with itching, swelling of lips, tongue, or face, which are more likely to appear on the day treatment with this medication starts
• Signs of liver disease (including liver failure), such as yellowing of the skin or the white part of the eyes (jaundice), nausea or vomiting, pain in the right side of the abdominal area, dark urine (brown color), decreased appetite, fatigue, and abnormal liver function test results. In a small number of cases, liver failure could lead to a liver transplant.

• Risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML). Symptoms of PML may be similar to those of a multiple sclerosis relapse. You may also experience symptoms that you may not notice yourself, such as mood or behavior changes, memory loss, speech or communication problems, which your doctor may need to investigate further to rule out PML. Therefore, if you think your multiple sclerosis is getting worse or if you or those close to you notice any new or unusual symptoms, it is very important to inform your doctor as soon as possible.
• Cryptococcal infections (a type of fungal infection), including cryptococcal meningitis with symptoms such as headache accompanied by neck stiffness, sensitivity to light, nausea, and/or confusion.
• Merkel cell carcinoma (a type of skin cancer). Possible signs of Merkel cell carcinoma include the formation of a painless nodule of flesh-colored or blue-red color, usually on the face, head, or neck. Merkel cell carcinoma can also appear as a firm and painless nodule or mass. Long-term sun exposure and a weakened immune system can affect the risk of developing Merkel cell carcinoma.
• After stopping treatment with fingolimod, multiple sclerosis symptoms may recur and may be worse than they were before or during treatment.
• Autoimmune form of anemia (decrease in red blood cell count) in which red blood cells are destroyed (autoimmune hemolytic anemia).

If you experience any of these symptoms, inform your doctor immediately.

Other Side Effects

Very Common(may affect more than 1 in 10 people):

• Influenza virus infection with symptoms such as fatigue, chills, sore throat, joint or muscle pain, fever.
• Feeling of pressure or pain in the cheeks and forehead (sinusitis).
• Headache.
• Diarrhea.
• Back pain.
• Blood tests with abnormal liver enzyme levels.
• Cough.

Common(may affect up to 1 in 10 people):

• Verseicolor tinea (fungal skin infection).
• Dizziness.
• Severe headache, usually accompanied by nausea, vomiting, and sensitivity to light (migraine).
• Low white blood cell count (lymphocytes, leukocytes).
• Weakness.
• Rash with itching, redness of the skin, and burning (eczema).
• Itching.
• Increased blood levels of certain lipids (triglycerides).
• Hair loss.
• Difficulty breathing.
• Depression.
• Blurred vision (see also the section on macular edema under the heading "Some side effects can be serious or potentially serious").
• Hypertension (this medication may cause a slight increase in blood pressure).

• Muscle pain.
• Joint pain.

Uncommon(may affect up to 1 in 100 people):

• Low levels of certain white blood cells (neutrophils)
• Depressive mood
• Nausea

Rare(may affect up to 1 in 1,000 people):

• Vascular disorders
• Nervous system disorders
• Lymphatic system cancer (lymphoma)

Frequency Not Known(cannot be estimated from available data):

• Peripheral inflammation

If you consider any of the side effects you are experiencing to be serious, inform your doctor.

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Fingolimod Neuraxpharm

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the packaging and on the aluminum blister after EXP. The expiration date is the last day of the month indicated.

Do not store above 25°C.

Keep in the original packaging to protect from light and moisture.

Do not use any packaging that is damaged or shows signs of tampering.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofFingolimod Neuraxpharm

The active ingredient is fingolimod. Each hard capsule contains fingolimod hydrochloride, equivalent to 0.5 mg of fingolimod.

The other ingredients are:

• Hard capsule contents: microcrystalline cellulose (E 460), low-substituted hydroxypropylcellulose (E 463), magnesium stearate (E 470b).
• Hard capsule shell: gelatin, titanium dioxide (E171).
• Printing ink: shellac (E 904), propylene glycol (E 1520), potassium hydroxide, black iron oxide (E 172).

Appearance of the Product and Package Contents

This medication has a white opaque body and a white opaque cap with black printing "FIN 0.5".

This medication is available in packages containing 7, 28, or 98 hard capsules.

Not all package sizes may be marketed.

Marketing Authorization Holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 – Sant Joan Despí

Barcelona - Spain

Manufacturer

Prasfarma, S.L.

C/ Sant Joan, 11-15

08560 – Manlleu

Barcelona - Spain

or

Neuraxpharm Arzneimittel GmbH

Elisabeth-Selbert-Str. 23,

40764 Langenfeld

Germany

This medication is authorized in the Member States of the European Economic Area under the following names:

Germany: Fingolimod neuraxpharm 0.5 mg Hartkapseln

Spain: Fingolimod Neuraxpharm 0.5 mg hard capsules

Austria: Fingolimod neuraxpharm 0.5 mg Hartkapseln

Date of the Last Revision of this Leaflet:June 2022

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/